Clinical trial Recruiting at 2 sites Interventional Ages 18 to 80

Ketogenic diet for patients with high-grade gliomas and brain metastases

Official title: A "Classic" Ketogenic Diet as a Complementary Therapeutic Management on Patients With High-grade Gliomas and Brain Metastases.

Run by Attikon Hospital · NCT05564949 · Data updated 2026-11-12

This study is testing if a special high-fat, low-carb diet can help people with aggressive brain tumors live longer and feel better.

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Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment15 (estimated)
SponsorAttikon Hospital
Academic / other
Drugs / interventionschemotherapy, radiation
Locations2 sites (Chaïdári, Athens and 1 other locations)
StatusRecruiting
StartedSeptember 20, 2022
Main results expectedOctober 30, 2025
Study endsFebruary 28, 2026
Registry record updatedMay 31, 2025
Trial IDNCT05564949 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-80 with newly diagnosed, histologically confirmed glioblastoma grade 4 or secondary metastases who can adhere to the ketogenic diet.

Probably not a fit

Patients with diabetes mellitus or those with a life expectancy greater than three months may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of a classic ketogenic diet (CKD) on patients diagnosed with high-grade gliomas and brain metastases. The CKD is designed to reduce glucose intake and promote ketosis, potentially extending survival for these patients. Participants will receive a tailored diet plan developed by dieticians to meet their energy needs while achieving ketosis. The primary outcome is to assess the efficacy of this dietary intervention compared to historical controls. The study aims to provide insights into the therapeutic potential of dietary changes in managing aggressive brain tumors.

Why it matters

Potential benefit: If successful, this approach could significantly extend the survival of patients with high-grade gliomas and brain metastases.

How similar studies have gone: While evidence for the ketogenic diet in clinical practice is limited, recent findings suggest potential therapeutic effects, indicating that this approach is novel and may offer new insights.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age 18-80
* Karnofsky Performance Score of 50 or more.
* Newly diagnosed, histologically confirmed glioblastoma grade 4, or secondary metastases or progression after surgical resection, radiation and chemotherapy.
* Normal function of liver and kidneys
* Ability to sign informed consent form

Exclusion Criteria:

* Diabetes mellitus
* Life expectancy \>3 months
* Inability to adhere to diet
* Inability to give informed consent form
* Cholecystectomy last 1 year (before the study entry)
* Diagnosis of genetic disorder of fat metabolism

Where it's running

  • Arezina Kasti
    Chaïdári, Athens, Greece
    Recruiting
  • Attikon University General Hospital
    Athens, Greece
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.